FDA.reportPublic FDA data

Handy Solutions Headache Pain Relief

Product NDC
67751-215
11-digit product format
677510215
Labeler code
67751
Product ID
67751-215_1626df04-bddf-e345-e063-6394a90a6fcc
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Aspirin, Caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Navajo Manufacturing Company Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-23
Substance
CAFFEINE; ACETAMINOPHEN; ASPIRIN
Active strength
65; 250; 250 mg/1; mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct67751-215IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67751-21567751-215-01IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Handy Solutions Headache Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAFFEINE65 mg/1
ACETAMINOPHEN250 mg/1
ASPIRIN250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3G6A5W338EInternal UNII lookup
362O9ITL9DInternal UNII lookup
R16CO5Y76EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308297Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e5481abe-6971-2bc5-e053-2995a90ae895Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67751-215-012024-04-15C16284748780-11030e365-58d7-111a-e063-dadaa90a10e2Handy Solutions Headache & Pain Relief
67751-215-012024-01-30C16284748780-11030e365-58d7-111a-e063-dadaa90a10e2Handy Solutions Headache & Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-215-01Handy Solutions Headache Pain Relief2 in 1 PACKETTABLET, FILM COATED22
67751-215-01Handy Solutions Headache Pain Relief2 in 1 CARTONTABLET, FILM COATED22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-215HANDY SOLUTIONS HEADACHE PAIN RELIEF (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [NAVAJO MANUFACTURING COMPANY INC.]2Current NDC, Legacy NDC, 2 package rows20240417_e5481abe-6971-2bc5-e053-2995a90ae895.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 30 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bayer Rapid ReliefASPIRIN/CAFFEINE ORAL POWDERBayer HealthCare LLC.f1fecbb0-5b55-fe8f-e053-2995a90a09772025-12-05WarningsExact identifier
application number: M013
Headache Relief, Extra Strength 24/7 Life by 7-ElevenACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET, FILM COATEDLil' Drug Store Products, Inc.45381b1c-2acd-1524-e063-6394a90a83d92025-12-05WarningsExact identifier
application number: M013
Acetaminophen Easy Tabs Extra StrengthACETAMINOPHENUnited Natural Foods, Inc. dba UNFI729132cd-f209-447a-8949-a90b5a5c01da2025-12-05WarningsExact identifier
application number: M013
Menstrual Pain Relief CompleteACETAMINOPHEN, PYRILAMINE MALEATE, CAFFEINEShield Pharmaceuticals Corp05fda811-d65f-41b2-89e4-297cdddb3d992025-12-05WarningsExact identifier
application number: M013
aspirinASPIRINHealth Pharma USA, LLC3165b0a3-556b-6abe-e063-6394a90a76822025-12-04WarningsExact identifier
application number: M013
Bayer Genuine AspirinASPIRINBayer HealthCare LLC.44a08904-68b9-4d06-a28d-21aae3d6140c2025-12-04WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENGeri-Care Pharmaceutical Corp7a29dde6-a177-6206-e053-2991aa0a01f22025-12-04WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENGeri-Care Pharmaceutical Corp7570aaa2-3238-4cd3-b788-915caa970dba2025-12-04WarningsExact identifier
application number: M013
Bayer HeadacheASPIRIN AND CAFFEINEBayer HealthCare LLC.c0a92873-0914-6a86-e053-2995a90ac41c2025-12-04WarningsExact identifier
application number: M013
Alka-Seltzer Original FlavorALKA-SELTZER ORIGINAL FLAVORBayer HealthCare LLC.07478020-5ba0-3b67-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M013
Alka-Seltzer Plus Severe Sinus Cold and Cough Liquid GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.0dba1329-5b0d-5688-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M013
Alka-Seltzer Plus Cold Medicine Sparkling OriginalASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.78537dcf-b157-4b67-a8b2-5cb1448151662025-12-04WarningsExact identifier
application number: M013
BAYER Aspirin Extra Strength CapletsBAYER ASPIRIN EXTRA STRENGTHBayer HealthCare LLC.0ae64cdb-4ea0-23af-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M013
Bayer Chewable - Aspirin Regimen Low Dose Aspirin Cherry FlavoredASPIRINBayer HealthCare LLC.070d5713-e018-2913-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M013
Bayer Low DoseASPIRINBayer HealthCare LLC.075b103e-0bb4-4b7a-ac0e-5645bcbd0a072025-12-04WarningsExact identifier
application number: M013
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.5be36a7f-7d1f-468d-9c29-92c8cd3ef1bc2025-12-04WarningsExact identifier
application number: M013
Bayer Aspirin Regimen enteric coatedASPIRINBayer HealthCare LLC.0c6ae05f-7634-34d1-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M013
aspirin pain reliefASPIRINRite Aid Corporationae9d9977-7576-4894-8a32-454828abec9a2025-12-04WarningsExact identifier
application number: M013
ASPIRINASPIRINRMT HEALTH LLC2bacffd1-4870-73af-e063-6294a90a19c82025-12-02WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINERite Aid Corporationd9caee45-be43-45ec-927f-e7fec5c14f072025-12-02WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSNe5481abe-6971-2bc5-e053-2995a90ae8952
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCDe5481abe-6971-2bc5-e053-2995a90ae8952
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSYe5481abe-6971-2bc5-e053-2995a90ae8952

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67751-215-01677510215012 PACKET in 1 CARTON (67751-215-01) / 2 TABLET, FILM COATED in 1 PACKET2 packet2021-09-230000-00-00NoNoCurrent